Gilead licenses hepatitis therapy in India

ilead Sciences has licensed seven India-based generic drugmakers to bring cheaper versions of Sovaldi to 91 countries, expanding the reach of a hepatitis C drug that is sold for $84,000 in the United States.

The drug's pricing has drawn criticism from pharmacy benefit managers, as well as questions from Sens. Charles Grassley, R-Iowa, and Ron Wyden, D-Ore., who have demanded to know how Gilead came up with the figure. The agreements in India were announced amid protests from activist groups that said the licenses failed to cover key high-burden nations like China, Brazil, Mexico and Thailand.

"Our view is that the competition and the capabilities of these partners will bring down the price," Gregg Alton, an executive vice president at Foster City, California-based Gilead, said at a news conference in New Delhi.

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Gilead chose Indian partners with "the capability of large-scale manufacturing, high-quality manufacturing, and low- cost manufacturing," Alton said. They have "the ability to supply the markets we're talking about."

The U.S. drugmaker plans to sell its branded version of Sovaldi in India at a cost of $900 for 12 weeks of therapy, Alton said. The drug will probably reach that market by the end of next year if clinical trials are run, and Gilead is in talks with the Indian regulator to waive the trial requirement.

As many as 150 million people in the world live with chronic hepatitis C infection, according to the World Health Organization. The most common modes of infection from the blood- borne virus are unsafe injection practices, inadequate sterilization of medical equipment, and unscreened blood and blood products.

The company didn't stipulate prices for the low-cost generic versions, Alton said. The manufacturers won't charge more than Gilead's "benchmark" $900 price, said Bhavesh Shah, director of international marketing at Hetero. Generic versions of Sovaldi will be available in India next year, sometime between April and September, he said.

The licenses announced Monday also allow the generic manufacturers to produce an experimental pill that combines Sovaldi with another Gilead hepatitis drug.

The lower price may still be too expensive for some patients in developing regions and some key countries haven't been included in the licensing deal, said Leena Menghaney, South Asia head of the Access Campaign at Doctors Without Borders.

The license enables the generic drugmakers to sell copies of Sovaldi in countries including Egypt, which has the world's highest prevalence of hepatitis C, as well as India and Indonesia. Not on the list is China, which has the greatest number of people infected, at 29.8 million, according to Doctors Without Borders.

The group has criticized the agreements for not bringing coverage to middle-income countries such as Ukraine, Thailand, Mexico and Brazil. More than 70 percent of patients with hepatitis C live in middle-income countries, according to the Geneva-based organization.

Alton said that 54 countries, or more than half of the 91 countries covered by the licenses, are middle-income markets.

"The licenses cover about 100 million people living with hepatitis C globally, representing about 54 percent of the total global infected population," he said. "About half of the world's population is covered."

Activists from Indian Drug Users Forum and Delhi Network of Positive People demonstrated outside the news conference, with signs reading "Gilead/Killead" and "Wanted: Crimes Against Access."

Gilead's application for a patent for Sovaldi in India is being challenged by Hyderabad-based Natco Pharma on the grounds that the therapy "lacks novelty" and isn't an "inventive step," according to a filing with the patent office.

The Initiative for Medicines, Access & Knowledge, a group of scientists and lawyers, has opposed the patent on similar grounds, saying that Sovaldi is based on "old science, existing compound," according to a statement last year.